NCT05172492

Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home

Efficacy of Endocare Treatment at Home on Pain in Women With Chronic Pelvic-perineal Pain Related to Endometriosis. EndoHome.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Lucine · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life. Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women. Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis. Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected. The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.

Conditions

• Endometriosis
• Chronic Pain
• Pelvic Pain

Interventions

Type	Name	Description
DEVICE	Endocare	Endocare will be administred through a virtual reality headseat used one to twice a day.
DEVICE	Digital control	Digital control will be administred through a virtual reality headseat used one to twice a day.

Timeline

• Start date: 2021-12-07
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-12-29
• Last updated: 2022-01-04

Locations

1 site across 1 country: France